This qui tam case settled for $190 million in 2004 after 8 years of litigation in the District of Massachusetts. Pfizer also paid a $240 million criminal fine for violations of the Food, Drug and Cosmetic Act. The allegations centered upon Parke Davis's illegal promotion of unapproved uses for one of its drugs, Neurontin. The qui tam plaintiff, David Franklin, was a microbiologist with a PhD who had been a medical liaison at Parke-Davis. Parke-Davis' parent company, Warner-Lambert, merged with Pfizer in 2000.
The Practice: Off-Label Promotion and Kickbacks
Dr. Franklin alleged that Parke-Davis campaigned to increase prescriptions for the epilepsy drug Neurontin by promoting "off-label" usage of the drug. While physicians may prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. Parke-Davis allegedly offered kickbacks and conducted sham research as part of the larger plan to promote off-label usage of the drug, causing false and misleading information about the drug's efficacy for those uses to be conveyed to physicians. In its press release announcing the settlement and criminal plea, the DOJ said that Parke-Davis's aggressive marketing scheme "corrupted the information process relied upon by doctors in their Medicaid decision making, thereby putting patients at risk."
Parke-Davis sales representatives allegedly touted unapproved uses for Neurontin such as relieving pain, headaches and psychiatric illnesses in a dishonest and misleading manner. Furthermore, Parke-Davis is alleged to have paid kickbacks to doctors in order to garner support for the drug's off-label usage, including fees for attending expensive dinners and lavish conferences in Miami, Hawaii and the Atlanta Olympics as "consultants." This marketing program allegedly raised the drug's sales from $97.5 million in 1995 to nearly $1.2 billion in 2000. According to press reports, about 80 percent of Neurontin prescriptions are for off-label uses.
The qui tam whistleblower, David Franklin, was employed by Parke-Davis as a medical liaison for five months during 1996. While medical liaisons are ordinarily affiliated with the research department of a drug manufacturer, Franklin alleged that Parke-Davis employed medical liaisons to act exclusively as sales representatives. Medical liaisons were "instructed to make exaggerated or false claims concerning the safety and efficacy of Parke-Davis drugs for off-label uses" and "encouraged to misrepresent their scientific credentials and to pose as research personnel, rather than as sales representatives." Franklin said that he was personally trained "to actively deceive physicians with contrived data, falsified 'leaks' from clinical trials, scientifically flawed reports, or 'success stories' that stated that Neurontin was highly effective in the treatment of a variety of pain syndromes." Furthermore, he was instructed to tell physicians that data existed to support dosages of up to 4800 mg per day whereas the clinical tests performed had only proven the safety and effectiveness of 1800 mg daily dosages of Neurontin. According to Franklin, he was instructed to go by the title of "Doctor" with the assumption that physicians would interpret his PhD as a medical degree and rely on his professional acumen. Franklin alleged that his employer concealed its actions by "shredding documents, falsifying documents, and encouraging medical liaisons to conduct their marketing activities without leaving a 'paper trail' that might be discovered by the FDA."
Troubled by his involvement and increasingly convinced his behavior was illegal, Mr. Franklin quit his job at Parke-Davis on July 29, 1996, just five months after starting. Immediately thereafter he consulted an attorney and brought his qui tam suit.
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